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21 July 2008

[Federal Register: July 21, 2008 (Volume 73, Number 140)]

[Notices]
[Page 42411-42414]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy08-120]
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DEPARTMENT OF VETERANS AFFAIRS
Determination of Presumption of Service Connection Concerning
Illnesses Discussed in National Academy of Sciences Report on Gulf War
and Health: Updated Literature Review of Sarin
AGENCY: Department of Veterans Affairs.
ACTION: Notice.
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SUMMARY: As required by law, the Department of Veterans Affairs (VA)
hereby gives notice that the Secretary of Veterans Affairs, under the
authority granted by the Persian Gulf War Veterans Act of 1998, Public
Law 105-277, title XVI, 112 Stat. 2681-742 through 2681-749 (codified
in part at 38 U.S.C. 1118), has determined that there is no basis to
establish a presumption of service connection for any of the diseases,
illnesses, or health effects discussed in the August 2004 report of the
National Academy of Sciences, titled ``Gulf War and Health: Updated
Literature Review of Sarin,'' based on exposure to sarin during service
in the Persian Gulf during the Persian Gulf War.
FOR FURTHER INFORMATION CONTACT: Maya Ferrandino, Regulations Staff
(211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, (727) 319-5847.
SUPPLEMENTARY INFORMATION:
I. Statutory Requirements
The Persian Gulf War Veterans Act of 1998, Public Law 105-277,
title XVI, 112 Stat. 2681-742 through 2681-749 (codified in part at 38
U.S.C. 1118), and the Veterans Programs Enhancement Act of 1998, Public
Law 105-368, 112 Stat. 3315, directed the Secretary to seek to enter
into an agreement with the National Academy of Sciences (NAS) to review
and evaluate the available scientific evidence regarding associations
between illnesses and exposure to toxic agents, environmental or
wartime hazards, or preventive medicines or vaccines to which service
members may have been exposed during service in the Persian Gulf during
the Persian Gulf War. Congress directed NAS to identify agents,
hazards,
[[Page 42412]]
medicines, and vaccines to which service members may have been exposed
during service in the Persian Gulf during the Persian Gulf War.
Congress mandated that NAS determine, to the extent possible: (1)
Whether there is a statistical association between exposure to the
agent, hazard, medicine, or vaccine and the illness, taking into
account the strength of the scientific evidence and the appropriateness
of the scientific methodology used to detect the association; (2) the
increased risk of illness among individuals exposed to the agent,
hazard, medicine, or vaccine; and (3) whether a plausible biological
mechanism or other evidence of a causal relationship exists between
exposure to the agent, hazard, medicine, or vaccine, and the illness.
Section 1602 of Public Law 105-277 provides that whenever the
Secretary determines, based on sound medical and scientific evidence,
that a positive association (i.e., the credible evidence for the
association is equal to or outweighs the credible evidence against the
association) exists between exposure of humans or animals to a
biological, chemical, or other toxic agent, environmental or wartime
hazard, or preventive medicine or vaccine known or presumed to be
associated with service in the Southwest Asia theater of operations
during the Persian Gulf War and the occurrence of a diagnosed or
undiagnosed illness in humans or animals, the Secretary will publish
regulations establishing presumptive service connection for that
illness. If the Secretary determines that a presumption of service
connection is not warranted, he is to publish a notice of that
determination, including an explanation of the scientific basis for
that determination. The Secretary's determination must be based on
consideration of the NAS reports and all other sound medical and
scientific information and analysis available to the Secretary.
Although Public Law 105-277 does not define ``credible evidence,''
it does instruct the Secretary to ``take into consideration whether the
results (of any study) are statistically significant, are capable or
replication, and withstand peer review.'' Simply comparing the number
of studies that report a significantly increased relative risk to the
number of studies that report a relative risk that is not significantly
increased is not a valid method for determining whether the weight of
evidence overall supports a finding that there is or is not a positive
association between exposure to an agent, hazard, or medicine or
vaccine and the subsequent development of the particular illness.
Because of differences in statistical significance, confidence levels,
control for confounding factors, and other pertinent characteristics,
some studies are clearly more credible than others, and the Secretary
has given the more credible studies more weight in evaluating the
overall weight of the evidence concerning specific illnesses.
II. NAS Reports on Sarin
NAS issued its initial report titled, Gulf War and Health, Volume
1: Depleted Uranium, Sarin, Pyridostigmine Bromide, Vaccines, on
January 1, 2000. In that report, NAS limited its analysis to the health
effects of depleted uranium, the chemical warfare agent sarin,
vaccinations against botulism toxin and anthrax, and pyridostigmine
bromide, which was used in the Gulf War as a pretreatment for possible
exposure to nerve agents. On July 6, 2001, VA published a notice in the
Federal Register announcing the Secretary's determination that the
available evidence did not warrant a presumption of service connection
for any disease discussed in that report, including sarin. See 66 FR
35702.
NAS issued a supplemental report, titled ``Gulf War and Health:
Updated Literature Review on Sarin'' in August 2004. In that report,
the Committee focused on the health effects associated with exposure to
sarin and related compounds, including relevant epidemiologic studies.
This Notice addresses the August 2004 Update on sarin.
III. The Committee's Review
In the August 2004 Update on sarin, the Committee reviewed the
peer-reviewed literature published since its earlier 2000 report on
health effects associated with exposure to sarin and related compounds.
These included both animal and human studies. In reviewing published
studies, the Committee based its determinations on the strength of the
evidence of associations between compound exposure and human health
effects as reported in those studies. The Committee also considered
other relevant issues, including exposure to multiple chemicals and
genetic susceptibilities.
The literature search on sarin and cyclosarin located about 250
articles published after the 2000 report. The Committee relied only on
published peer-reviewed articles for their review, although each
article was carefully reviewed for its relevance and quality. The
Committee relied primarily upon epidemiological studies that involved
humans. Animal studies had a lesser role in its assessment of the
potential relationship between sarin exposure and health effects, and
were used, as in previous NAS studies, primarily for making assessments
of biological plausibility in support of epidemiological findings.
The Committee reviewed 19 epidemiological studies of sarin health
effects published since its original 2000 report. These included three
studies on non-Gulf War veterans, four studies of Gulf War veterans
potentially exposed at Khamisiyah, six population-based studies of U.S.
and U.K. Gulf War veterans using self-reported exposures, and six
studies of specific military units of Gulf War veterans also using
self-reported exposures. They also looked again at all of the studies
used in the 2000 report. The non-Gulf War veteran studies reviewed in
both the 2004 update and the earlier 2000 report were based on U.S.
military volunteers who had been exposed several decades ago to non-
lethal doses of sarin and other chemical warfare agents; on industrial
workers with documented acute exposure to sarin; and on victims of the
sarin terrorist attacks in Matsumoto City in 1994 and Tokyo in 1995.
The Committee pointed out that a major limitation of virtually all
human studies is a lack of good exposure information.
The Committee report pointed to the uncertainties surrounding the
Department of Defense (DoD) sarin exposure assessment for Khamisiyah,
and how those uncertainties limit the ability of studies that rely upon
that modeling data to provide strong evidence for the presence or the
absence of any association between sarin exposure and health outcomes.
They stated, ``none of the studies using exposure information showed
persistent neurological effects in Khamisiyah-exposed troops compared
to non-Khamisiyah exposed troops. Because of the uncertainty in the
exposure assessment models those studies do not provide strong evidence
for or against the presence of neurologic effects.'' Therefore, the
studies based upon the DoD Khamisiyah modeling had little impact on the
Committee's findings.
The Committee also reported on new published data regarding
experimental animals that were designed to mimic the potential
exposures in the Gulf War. These data had precipitated the interest in
an updated study of sarin health effects. The Committee reported that
the data were an important step in ``determining whether a biologically
plausible mechanism could underlie any long-term effects of low
exposure to chemical verge agents, but more work
[[Page 42413]]
needs to be conducted to elucidate potential mechanisms and clarify how
the cellular effects are related to any clinical effects that might be
seen.''
The Committee reported that, in the absence of carefully designed
human studies expressly of sarin's or cyclosarin's long-term health
effects at doses that do not produce acute signs and symptoms, the
Committee concludes that the data remain inadequate or insufficient to
determine whether persistent long-term effects are associated with low-
level sarin exposure.
At a briefing to VA in August 2004, when questioned about whether
NAS emphasis on human studies might overlook health concerns revealed
only in laboratory animal studies, the head of the Committee stated
that the Committee did thoroughly review available animal studies and
taken together, they failed to show consistent biological effects that
could be plausibly tied to potential clinical effects in humans. He
added that future animal studies might change that result.
IV. The Committee's Conclusions
In its report, the Committee weighed the strengths and limitations
of all the epidemiological evidence reviewed for the August 2004 Update
and in Gulf War and Health Volume 1, and reached its conclusions by
interpreting the new evidence in the context of the entire body of
literature. The Committee classified the evidence of an association
between exposure to sarin and cyclosarin and a specific health outcome
with reference to five categories: sufficient evidence of a causal
relationship, sufficient evidence of an association, limited/suggestive
evidence of an association, inadequate/insufficient evidence of an
association, and limited/suggestive evidence of no association.
Sufficient Evidence of a Causal Relationship: This
category means the evidence is sufficient to conclude that there is a
causal association between exposure to a specific agent and a specific
health outcome in humans. The evidence is supported by experimental
data and fulfills the guidelines for sufficient evidence of an
association. The evidence must be biologically plausible and satisfy
several of the guidelines used to assess causality, such as: strength
of association, dose-response relationship, consistency of association,
and a temporal relationship.
The Committee found there is sufficient evidence of a causal
relationship between acute high-dose exposure to sarin and acute
cholinergic syndrome that is evident seconds to hours subsequent to
sarin exposure and resolves in days to months. The Committee noted that
acute cholinergic syndrome has been recognized for decades, and that
the syndrome, as well as cholinergic signs and symptoms, is evident
seconds to hours after exposure and usually resolves in days to months.
Sufficient Evidence of an Association: This category means
the evidence is sufficient to conclude that there is a positive
association. That is, a consistent positive association has been
observed between exposure to a specific agent and a specific health
outcome in human studies in which chance and bias, including
confounding, could be ruled out with reasonable confidence. For
example, several high-quality studies report consistent positive
associations, and the studies are sufficiently free of bias, including
adequate control for confounding.
The Committee made no conclusions in this category.
Limited/Suggestive Evidence of an Association: This
category means the evidence is suggestive of an association between
exposure to a specific agent and a specific health outcome, but the
body of evidence is limited by the inability to rule out chance and
bias, including confounding, with confidence. For example, at least one
high-quality study reports a positive association that is sufficiently
free of bias, including adequate control for confounding. Other
corroborating studies provide support for the association, but they are
not sufficiently free of bias, including confounding. Alternatively,
several studies of lower quality show consistent positive associations,
and the results are probably not due to bias, including confounding.
The Committee found there is limited/suggestive evidence of an
association between exposure to sarin at doses sufficient to cause
acute cholinergic signs and symptoms and a variety of subsequent long-
term neurological effects. The Committee noted that many health effects
are reported in the literature to persist after such high-dose sarin
exposure: fatigue, headache, visual disturbances (asthenopia, blurred
vision, and narrowing of the visual field), asthenia, shoulder
stiffness, and symptoms of posttraumatic stress disorder. The Committee
further stated that such sarin exposure has also been followed by
abnormal test results, of unknown clinical significance, on the digit
symbol test of psychomotor performance, EEG records of sleep, event-
related potential, visual evoked potential, and computerized
posturography.
The Committee based its conclusion on the persistent effects seen
in retrospective studies of three exposed populations in which acute
cholinergic signs and symptoms were documented as acute effects of
exposure. However, the Committee explained that while a review of the
literature published since the Committee's initial report confirmed the
effects seen in those populations, the data, taken together, were not
adequate to increase confidence in the evidence to that of sufficient
evidence of an association.
Inadequate/Insufficient Evidence: This category means the
evidence is of insufficient quantity, quality, or consistency to permit
a conclusion regarding the existence of an association between exposure
to a specific agent and a specific health outcome in humans.
The Committee found there is inadequate/insufficient evidence to
determine whether an association does or does not exist between
exposure to sarin at low doses insufficient to cause acute cholinergic
signs and symptoms and subsequent long-term adverse neurological health
effects. In the absence of carefully designed human studies expressly
of sarin or cyclosarin's long-term health effects at doses that do not
produce acute signs and symptoms, the Committee concluded that the data
remain inadequate or insufficient to determine whether such long-term
effects are associated with low-level sarin exposure.
The Committee also found there is inadequate/insufficient evidence
to determine whether an association does or does not exist between
exposure to sarin and subsequent long-term cardiovascular effects.
Studies of persistent cardiovascular effects after sarin exposure have
been inconsistent. Therefore, the Committee concluded that the data are
inadequate or insufficient to determine whether an association exists.
Limited/Suggestive Evidence of No Association: This
category means the evidence is consistent in not showing a positive
association between exposure to a specific agent and a specific health
outcome after exposure of any magnitude. A conclusion of no association
is inevitably limited to the conditions, magnitudes of exposure, and
length of observation in the available studies. The possibility of a
very small increase in risk after exposure studied cannot be excluded.
The Committee made no conclusions in this category.
[[Page 42414]]
V. Response to the NAS Report
After careful review of the findings of the August 2004 NAS report,
the Secretary has determined that the conclusions contained in the
report do not provide adequate basis to support a presumption of
service connection for any health condition resulting from sarin
exposure. Specifically, the Secretary has determined that the 2004 NAS
Committee conclusions concerning both acute high-dose exposure to sarin
and low-level exposure to sarin are consistent with the findings in the
2000 NAS report, and therefore do not warrant any change in current VA
policy.
Following the 2000 NAS report, VA determined that a presumption
based on acute high-dose exposure was not warranted for a number of
reasons. First, VA and Department of Defense have determined, with a
high degree of confidence, that no service members were exposed to
levels of sarin sufficient to induce acute cholinergic syndrome.
Further, if such exposures had occurred, the symptoms would have been
present within seconds to hours following exposure and would be
compensable by VA on a direct service-connection basis. Additionally,
any long-term neurological effects would be compensable under VA
presumptions for undiagnosed illness. See 38 CFR 3.317. Finally,
because it is very unlikely that a presumption would benefit anyone,
such a presumption would likely be confusing and have a negative impact
on the claims adjudication process.
Nothing in the 2004 NAS report changes the bases for VA's prior
determination. The 2004 report notes that current available information
is ``consistent with the absence of reports of acute cholinergic
symptoms by medical personnel or veterans'' and that the level of
exposure experienced by service members during the Gulf War ``would
have been insufficient to produce the cholinergic syndrome.''
Similarly, the Secretary has determined that the conclusions
contained in the 2004 NAS report regarding long-term health effects
from exposure to low levels of sarin are essentially identical and lend
further support to the conclusions contained in the 2000 report. Based
upon the findings contained in the 2000 NAS report, the Secretary
determined that there was not an adequate basis to support establishing
a presumption of service connection for any health problem resulting
from sarin exposure. NAS's findings in the 2004 Update provide further
support for existing VA policy on these issues.
In conclusion, the Secretary has determined that the findings in
the 2004 NAS report did not provide any new basis to establish a
presumption of service connection for any diseases, illnesses, or
health effects resulting from exposure to sarin during service in the
Persian Gulf during the Persian Gulf War. Therefore, the Secretary has
determined that there is no scientific basis to revise earlier policy
determinations published in the Federal Register at 66 FR 35702 on July
6, 2001, on health effects from exposure to sarin based upon the NAS's
2000 Report.
Approved: July 11, 2008.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.
[FR Doc. E8-16525 Filed 7-18-08; 8:45 am]
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